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Endoluminal GERD treatments

CSR on endoluminal GERD treatments (Esophyx)

The new CSR addresses the evidence around Stretta and Esophyx, as well as provide evidence-based answers to the following clinically relevant questions that were developed by the SAGES Guidelines Committee using the PICOD methodology

The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has issued a Clinical Spotlight Review (CSR) Guideline statement on two endoscopic treatments for the treatment of gastroesophageal reflux disease (GERD), Esophyx device and Stretta. In 2013, the SAGES Guidelines Committee published a review of the available evidence on these two procedures. As there have been numerous, quality studies and vast literature accumulation since the previous SAGES publication, the SAGES Guidelines Committee decided to update its recommendations on these techniques.

The new CSR addresses the evidence around Stretta and Esophyx, as well as provide evidence-based answers to the following clinically relevant questions that were developed by the SAGES Guidelines Committee using the PICOD methodology

A systematic literature search was performed in July 2016 on Stretta and EsophyX. Two members of the SAGES guidelines committee reviewed the retrieved abstracts and pulled the full text of relevant articles for detailed review. Both the quality of the evidence and the strength of the recommendation for each of the below guidelines was assessed according to the GRADE system. There is a 4-tiered system for quality of evidence (very low (+), low (++), moderate (+++), or high (++++)) and a 2-tiered system for strength of recommendation (weak or strong).

EsophyX

EsophyX (Endogastric Solutions) is an endoscopic device used to create a transoral incisionless fundoplication (TIF). It is inserted orally within a thin, flexible tube and deployed inside the stomach to create a full thickness plication of the stomach fundus at the GE junction, thereby resembling an endoscopic fundoplication.

Figure 1: EsophyX device

The current TIF 2.0 technique (the initial TIF 1.0 technique is no longer recommended) generates a physiological valve via fasteners placed on the far posterior and anterior sides of the lesser curvature, with additional fasteners placed 1-3cm proximal to the GE junction (Figure 2). The polypropylene “H-shaped” fasteners aid the “serosa to serosa” fusion and promote the reconstruction of an anatomical valve similar to traditional fundoplication.

Figure 2: A) A bad valve B) Fastner delivery C) Repair with Helical Retractor D) Repaired tissue E) Repaired tissue (with wrap) F) Repaired valve with fastners

Under general anaesthesia, the procedure is typically accomplished in less than an hour and requires a surgeon to operate the device, while an assistant operates the gastroscope. Patients can return to work and normal activities within a few days, making TIF an attractive option for the treatment of GERD.

Since the introduction of TIF in clinical practice, numerous studies have reported on its outcomes. A systematic literature search of the available evidence revealed sixty papers on TIF. Since the publication of the prior SAGES report on endoluminal techniques, five randomised controlled trials, one systematic review, and one meta-analysis have been published. These studies provide a clearer picture of the clinical effectiveness and safety of the procedure. Moreover, eight observational studies and an additional systematic review provide insight into longer term outcomes of the TIF 2.0 procedure. In the following text we will address the questions pertinent to this procedure.

All available randomised controlled trials have compared TIF 2.0 with medical treatment (PPI), but no study has compared it with surgical fundoplication. There is significant heterogeneity in the primary outcomes of the five available RCTs. Two of the trials assessed elimination of troublesome regurgitation, one assessed clinical remission of GERD without PPIs, one assessed improvement in GERD symptom scores, and one assessed the changes in baseline impedance and heartburn severity.

To compare the results of the available RCTs, a meta-analysis was conducted in which the primary outcome was the responsiveness of GERD to TIF treatment versus control intervention. They defined responsiveness as an improvement of at least 50% in the GERD health-related quality of life (GERD-HRQL) scores, remission of heartburn and regurgitation, or in the absence of these reported outcomes, complete cessation of PPI use. Among patients included in four of the available RCTs, those who underwent TIF were more likely to attain the standard of responsiveness at six months compared with the control group treated with PPIs (66% vs 30.5%, respectively; pooled RR: 2.44, 95% CI: 1.25–4.79, p = 0.009). Compared with PPI treatment, TIF has clearly demonstrated to be more effective in controlling patient GERD symptoms six months post-procedure.

Compared with sham controls (mean difference: -4.25, 95% CI: -7.87 to -0.63, I2=78%, p= 0.02), oesophageal acid exposure time has been shown to improve significantly after TIF and be similar to that of patients on PPIs (mean difference: -0.34, 95% CI: -4.02 to 3.33, I2= 87%, p= 0.85). Concerning the total number of reflux episodes, patients undergoing TIF were found to have fewer episodes compared with those on PPIs, with a mean difference of -29.07 (95%CI: -39.17 to -18.98, I2=45%, p<0.00001). The incidence of acid reflux episodes reveals no significant differences between TIF and PPI treatment with a mean difference of 10.43 (95% CI: -4.02 to 24.88, I2= 0%, p= 0.16).18

As reported in ten observational studies, patient satisfaction is between 45 and 86% at a mean of six months after the TIF procedure, with a calculated weighted average rate of 69.15%.18

A small, retrospective cohort study has reported TIF outcomes in neurologically impaired children with GERD. At a follow-up of 8.2 ± 4.2 months, the authors found that TIF effectively resolved GERD in ten out of eleven children. However, the EsophyX System is not approved by the FDA for use in paediatric patients, nor does the manufacturer recommend its use in children. The device itself requires a 54-French diameter delivery system, limiting application to patients larger than 25kg, thereby excluding infants and toddlers. Presently, there is insufficient data to support the use of TIF in the paediatric population.

There are no quality studies available that compare TIF to surgical fundoplication, nor does evidence exist regarding the impact of TIF on long term complications of GERD such as Barrett’s oesophagus, stricture formation, or cancer. All studies used TIF for the primary treatment of GERD and no evidence exists for post-surgical GERD treatment. The most recent SAGES guidelines on the treatment of GERD23 indicate that the effectiveness of laparoscopic fundoplication on GERD outcomes is superior to that of PPIs and TIF.

Sixteen studies (4 RCTs and 12 prospective observational trials)18 have reported the occurrence of severe adverse events. Of a total of 781 patients who underwent TIF, severe adverse events occurred in 19 patients, yielding an incidence rate of 2.4%. Severe adverse events included seven perforations, five instances of post-TIF bleeding, four cases of pneumothorax, one requiring intravenous antibiotics, and one case involving severe epigastric pain. One death was reported 20 months after the TIF procedure, with an unknown causal relationship.

A potential concern is that a failed TIF may increase the risk of a subsequent fundoplication, which might result from scarring and the presence of H fasteners. Three studies have reported outcomes after failed TIF and have demonstrated that fundoplication can be accomplished safely and effectively. Reasons for failure during surgery often include breakdown of fundoplication and the presence of a hiatal hernia.

Based on the findings of the meta-analysis that also examined long- term outcomes after the procedure reported by observational studies, the effectiveness of the procedure diminishes over time reaching a maximum level just over 70% at six months and just under 40% six years later. Six year outcomes have been reported on only 14 patients. Although most of the patients resumed PPI treatment during the long-term follow-up, PPI doses were reduced compared with their baseline.18

With regard to how does the comparative effectiveness of TIF 2.0 differ based on the surgeon’s experience, the review found that there are no reports directly addressing this question. The initial TIF 1.0 technique that created a gastro-gastric plication with fasteners fixed centrally on the greater curvature at the squamocolumnar junction of the esophagus to the gastric fundus did not work as well for reflux control and is no longer recommended. The TIF 2.0 technique generates a physiological valve via fasteners placed on the far posterior and anterior sides of the lesser curvature, with additional fasteners placed 1-3cm proximal to the GE junction. Since the number of fasteners appear to affect GERD outcomes, at least 14 H fasteners are recommended to be placed during the procedure.

Recommendation

Based on existing evidence, the CSR found that “TIF can be performed with an acceptable safety risk in appropriately selected patients. The procedure leads to better control of GERD symptoms compared with PPI treatment in the short term (6 months), but appears to lose effectiveness during longer term follow-up and is associated with moderate patient satisfaction scores. Objective GERD measures improve similarly after TIF 2.0 compared with PPI. No comparative, controlled trials exist between TIF and surgical fundoplication, but preliminary evidence suggests that the latter can be used safely after TIF failure. (Level of evidence +++, strong recommendation)."

Please click here to access part 2 (Stretta Therapy) of the CSR

To review the review statement, please click here

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